Trial Information

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted
Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with
suspicion of non-invasive bladder cancer.

Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen
is according to standard clinical practice in Denmark.

Recurrence of non-invasive bladder cancer is frequent, and this study is designed to
investigate whether Hexvix assisted TURB can reduce the early recurrence compared to
standard TURB

Inclusion Criteria:

- Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral
resection of the bladder

- Above 18 years

- Written informed consent obtained

Exclusion Criteria:

- Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting
in marked amounts of blood in the urine, which may interfere with fluorescence
cystoscopy. Where the bleed is light, the patient should not be excluded if in the
investigator's opinion, rinsing during cystoscopy will alleviate the possible
interference with fluorescence cystoscopy).

- Patient with porphyria.

- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.

- Participation in other clinical studies with investigational drugs either
concurrently or within the last 30 days.

- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative serum or urine pregnancy test at screening and use the contraceptive pill or
intrauterine device (IUD) during the treatments and for at least one month
thereafter).

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